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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Water Purification, General Medical Use
510(k) Number K191563
Device Name FILTRAY 2G Disposable Water Filters
Applicant
aqua-tools
26, rue Charles Edouard Jeanneret
Poissy,  FR 78300
Applicant Contact Virginie S. Grondin
Correspondent
aqua-tools
26, rue Charles Edouard Jeanneret
Poissy,  FR 78300
Correspondent Contact Virginie S. Grondin
Regulation Number876.5665
Classification Product Code
NHV  
Date Received06/13/2019
Decision Date 10/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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